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Bifocal Contact Lens Study for Adults With Age-Related Near Vision Loss

Primary Purpose

Presbyopia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Clerio Vision LIRIC-modified Bifocal Contact Lens

Johnson & Johnson 1-Day Acuvue Moist Multifocal Contact Lens

Johnson & Johnson 1-Day Acuvue Moist Contact Lens

Clerio Vision Single Vision Contact Lens

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring Refractive Errors, Myopia, Hyperopia, Astigmatism

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Legal age (at least 21) on the date the Informed Consent Form (ICF) is signed and have the capacity to provide voluntary informed consent
Able to read, understand and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.
Willing and able to comply with all study instructions/procedures.
Best Distance Spherical Corrected Visual Acuity (BDSCVA) in at least one eye of 20/25 (0.10 logMAR).
Physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
Previous experience with contact lenses.
Distance spectacle spherical correction in at least one eye within +/- 5D of the study lens power (-3.00D).
Habitual spectacle addition (at 40cm) of at least +1.00D.
Refractive astigmatism less than -2.75D.
Most recent complete eye examination was within the last 24 months of the date of study completion.

Exclusion Criteria:

Currently participating in any drug or device clinical investigation during the period of study participation.
Active anterior segment ocular disease or using any ocular medication for anterior segment disease (e.g. conjunctivitis, dry-eye disease).
Current or past condition that might have caused corneal distortion or anterior surface topography abnormalities (e.g. keratoconus, map-dot fingerprint or any other corneal dystrophies, corneal disease or trauma resulting in scarring, pterygium, pellucid marginal degeneration)
Previous refractive corneal surgery (e.g., laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), corneal transplant, Descemet's Stripping Endothelial Keratoplasty (DSEK) etc.).
Considered by the Investigator to not be a suitable candidate for participation.

Sites / Locations

Clerio Vision Research Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test Device

Control Devices

Arm Description

Within this arm the Clerio Vision LIRIC-modified Bifocal Contact Lens is administered.

Within this arm the Johnson & Johnson 1-Day Acuvue Moist Multifocal Contact Lens, Johnson & Johnson 1-Day Acuvue Moist Contact Lens, and Clerio Vision Single Vision Contact Lens are administered.

Outcomes

Primary Outcome Measures

Comparison of Through-Focus High Contrast logMAR Visual Acuity for the Test Bifocal Contact Lens Versus that of the Control Bifocal Contact Lens, the Control Single Vision Contact Lens 1, and the Control Single Vision Contact Lens 2

Visual acuity is measured under high contrast conditions (85% contrast relative to the chart background) at object testing distances of 5.3m, 2m, 1m, 67cm, 50cm and 40cm ("through-focus"), recorded in units of logMAR.

Secondary Outcome Measures

Comparison of Through-Focus Low Contrast logMAR Visual Acuity for the Test Bifocal Contact Lens Versus that of the Control Bifocal Contact Lens, the Control Single Vision Contact Lens 1, and the Control Single Vision Contact Lens 2

Visual acuity is measured under low contrast conditions (10% contrast relative to the chart background) at object testing distances of 5.3m, 2m, 1m, 67cm, 50cm and 40cm ("through-focus"), recorded in units of logMAR.

Comparison of Visual Quality for the Test Bifocal Contact Lens Versus that of the Control Bifocal Contact Lens, the Control Single Vision Contact Lens 1, and the Control Single Vision Contact Lens 2

Visual quality is a subjective rating that a participant chooses using an analog rating chart ranging from 0 to 100. Participants are asked to look at the letters that they can read, not the ones that they can't, and rate how sharp those letters are, with 0 denoting "unacceptable" and 100 denoting "excellent." They are asked to reduce their score if any halos, glare, or double vision are present.

Comparison of Fitting Performance for the Test Bifocal Contact Lens Versus that of the Control Bifocal Contact Lens, the Control Single Vision Contact Lens 1, and the Control Single Vision Contact Lens 2

Fitting performance is measured by visual observation of the contact lens on a participant's eye using a slit lamp biomicroscope and ocular measurement reticle. The position of the lens edge relative to the corneal boundaries both immediately before and immediately after a blink is measured.

Full Information

NCT ID

NCT03653715

First Posted

August 27, 2018

Last Updated

April 12, 2019

Sponsor

Clerio Vision, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03653715

Brief Title

Bifocal Contact Lens Study for Adults With Age-Related Near Vision Loss

Official Title

Clinical Performance Study of Clerio Single Vision and Bifocal Contact Lens Designs Immediately Following Insertion

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

August 6, 2018 (Actual)

Primary Completion Date

August 27, 2018 (Actual)

Study Completion Date

October 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Clerio Vision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of this study is to evaluate the distance, intermediate and near visual performance of Clerio designed single vision and Clerio designed LIRIC modified bifocal lenses (+2.00D add) compared to commercially available single vision and multifocal lenses.

Detailed Description

Clerio Vision Inc. has licensed a new femtosecond based laser procedure discovered by researchers at the University of Rochester known as Laser Induced Refractive Index Customization (LIRIC), which allows the alteration of the optical design of a finished soft hydrogel contact lens. Clerio Vision Inc. scientists have developed a diffractive multifocal optical design using the LIRIC procedure which shows an increase of the depth of focus of the contact lens when measured on an optical bench. It is hypothesized that a presbyopic patient wearing a soft contact lens of this design will experience an improvement in intermediate and near vision over that provided by their distance corrected single vision contact lenses, without significantly impacting their distance vision. The purpose of this feasibility study is the on-eye evaluation of the performance of the Clerio Vision designed and LIRIC modified soft contact lenses. Results from this study will guide future development of these potential products.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Presbyopia

Keywords

Refractive Errors, Myopia, Hyperopia, Astigmatism

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

This single center study is a device feasibility, two-arm, double-masked (participants and outcomes assessor), repeated measures, cross-sectional design. Each participant is tested with the four (4) study devices (i.e., contact lenses), one (1) test lens and three (3) control lenses, in randomized order. Participants are masked to each lens they wear.

Masking

ParticipantOutcomes Assessor

Masking Description

The Principal Investigator and Clinical Research Technicians, because they handle the contact lenses both in and out of their packaging, are not masked.

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test Device

Arm Type

Experimental

Arm Description

Within this arm the Clerio Vision LIRIC-modified Bifocal Contact Lens is administered.

Arm Title

Control Devices

Arm Type

Active Comparator

Arm Description

Within this arm the Johnson & Johnson 1-Day Acuvue Moist Multifocal Contact Lens, Johnson & Johnson 1-Day Acuvue Moist Contact Lens, and Clerio Vision Single Vision Contact Lens are administered.

Intervention Type

Device

Intervention Name(s)

Clerio Vision LIRIC-modified Bifocal Contact Lens

Other Intervention Name(s)

Clerio Vision Bifocal Contact Lens, Clerio Vision Multifocal Contact Lens, Laser-Induced Refractive Index Change (LIRIC) Bifocal Contact Lens

Intervention Description

Within this arm the investigational acofilcon B material bifocal contact lens, which has been modified with the laser and is the focus of the study, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes.

Intervention Type

Device

Intervention Name(s)

Johnson & Johnson 1-Day Acuvue Moist Multifocal Contact Lens

Other Intervention Name(s)

Commercially Available Multifocal Contact Lens, Control Multifocal Contact Lens, Etafilcon A

Intervention Description

Within this arm the control etafilcon A material bifocal contact lens, which is commercially available, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes.

Intervention Type

Device

Intervention Name(s)

Johnson & Johnson 1-Day Acuvue Moist Contact Lens

Other Intervention Name(s)

Commercially Available Single Vision Contact Lens, Control Single Vision Contact Lens, Etafilcon A

Intervention Description

Within this arm the control etafilcon A material single vision contact lens, which is commercially available, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes.

Intervention Type

Device

Intervention Name(s)

Clerio Vision Single Vision Contact Lens

Other Intervention Name(s)

Contamac 49 Single Vision Contact Lens, Control Single Vision Contact Lens, Acofilcon B

Intervention Description

Within this arm the control acofilcon B material single vision contact lens, the material of which is commercially available from Contamac Ltd, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes.

Primary Outcome Measure Information:

Title

Description

Time Frame

starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)

Secondary Outcome Measure Information:

Title

Description

Time Frame

starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)

Title

Comparison of Visual Quality for the Test Bifocal Contact Lens Versus that of the Control Bifocal Contact Lens, the Control Single Vision Contact Lens 1, and the Control Single Vision Contact Lens 2

Description

Time Frame

starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)

Title

Description

Time Frame

starting from visit 2 (after enrollment) and finishing with visit 3, the exit visit (up to 60 days after visit 2)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Legal age (at least 21) on the date the Informed Consent Form (ICF) is signed and have the capacity to provide voluntary informed consent Able to read, understand and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations. Willing and able to comply with all study instructions/procedures. Best Distance Spherical Corrected Visual Acuity (BDSCVA) in at least one eye of 20/25 (0.10 logMAR). Physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. Previous experience with contact lenses. Distance spectacle spherical correction in at least one eye within +/- 5D of the study lens power (-3.00D). Habitual spectacle addition (at 40cm) of at least +1.00D. Refractive astigmatism less than -2.75D. Most recent complete eye examination was within the last 24 months of the date of study completion. Exclusion Criteria: Currently participating in any drug or device clinical investigation during the period of study participation. Active anterior segment ocular disease or using any ocular medication for anterior segment disease (e.g. conjunctivitis, dry-eye disease). Current or past condition that might have caused corneal distortion or anterior surface topography abnormalities (e.g. keratoconus, map-dot fingerprint or any other corneal dystrophies, corneal disease or trauma resulting in scarring, pterygium, pellucid marginal degeneration) Previous refractive corneal surgery (e.g., laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), corneal transplant, Descemet's Stripping Endothelial Keratoplasty (DSEK) etc.). Considered by the Investigator to not be a suitable candidate for participation.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michele Lagana, OD

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clerio Vision Research Clinic

City

Rochester

State/Province

New York

ZIP/Postal Code

14607

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19529613

Citation

Ding L, Blackwell R, Kunzler JF, Knox WH. Large refractive index change in silicone-based and non-silicone-based hydrogel polymers induced by femtosecond laser micro-machining. Opt Express. 2006 Nov 27;14(24):11901-9. doi: 10.1364/oe.14.011901.

Results Reference

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PubMed Identifier

18641284

Citation

Ding L, Knox WH, Buhren J, Nagy LJ, Huxlin KR. Intratissue refractive index shaping (IRIS) of the cornea and lens using a low-pulse-energy femtosecond laser oscillator. Invest Ophthalmol Vis Sci. 2008 Dec;49(12):5332-9. doi: 10.1167/iovs.08-1921. Epub 2008 Jul 18.

Results Reference

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PubMed Identifier

21931133

Citation

Xu L, Knox WH, DeMagistris M, Wang N, Huxlin KR. Noninvasive intratissue refractive index shaping (IRIS) of the cornea with blue femtosecond laser light. Invest Ophthalmol Vis Sci. 2011 Oct 17;52(11):8148-55. doi: 10.1167/iovs.11-7323.

Results Reference

background

PubMed Identifier

24985471

Citation

Savage DE, Brooks DR, DeMagistris M, Xu L, MacRae S, Ellis JD, Knox WH, Huxlin KR. First demonstration of ocular refractive change using blue-IRIS in live cats. Invest Ophthalmol Vis Sci. 2014 Jul 1;55(7):4603-12. doi: 10.1167/iovs.14-14373.

Results Reference

background

PubMed Identifier

28866013

Citation

Wozniak KT, Elkins N, Brooks DR, Savage DE, MacRae S, Ellis JD, Knox WH, Huxlin KR. Contrasting cellular damage after Blue-IRIS and Femto-LASIK in cat cornea. Exp Eye Res. 2017 Dec;165:20-28. doi: 10.1016/j.exer.2017.08.018. Epub 2017 Aug 31.

Results Reference

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Bifocal Contact Lens Study for Adults With Age-Related Near Vision Loss

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